x

Cekindo Business International is now InCorp Indonesia. Learn more.

Our Services
Business Setup
Business Process Outsourcing
Immigration Consultation
Product Registration & Import
Compliance & Secretarial Services
Transfer Pricing Services
Other Services

Company Registration

business visa indonesia

Indonesia Business Visa

Business Outsourcing

Business Setup in Indonesia

There are several ways to break into the Indonesian market, but findin...

Learn More

Business License Indonesia

Apply for Business Permits and Licenses in Indonesia: The Easiest Way

Entrepreneurs worldwide can now experience the ease of applying for bu...

Learn More

Company Dissolution Services in Indonesia

Dissolving a company in Indonesia can pose a challenge for entrepreneu...

Learn More

Company Registration in Indonesia

Establishing a company is the first step to expanding your business op...

Learn More

Corporate Recovery & Bankruptcy or Insolvency Services in Indonesia

Corporate Recovery & Bankruptcy or Insolvency Services in Indonesia

To help businesses survive during this unfortunate time, InCorp provid...

Learn More

Land and Property Ownership in Indonesia

Learn About Property & Land Ownership in Indonesia

Obtaining property & land ownership in Indonesia offers some challenge...

Learn More

Mergers & Acquisitions (M&A) In Indonesia

The landscape for foreign investment in Indonesia continues to improve...

Learn More

Trademark Registration in Indonesia

Trademark Registration Services in Indonesia

Opting for a trademark registration service in Indonesia is the safest...

Learn More

Virtual Offices Indonesia

Open Your Serviced and Virtual Office in Indonesia

Renting a serviced or virtual office is an efficient way to start a fl...

Learn More

Business Process Outsourcing Services

Business process outsourcing in Indonesia is a viable option to stream...

Learn More

accounting services indonesia

Accounting Services in Indonesia

As your business grows, you will find that financial management and re...

Learn More

Financial Audit Services in Indonesia

In accordance with Indonesian company law, the board of directors is r...

Learn More

Employer of Record in Indonesia

In a world where remote hiring is becoming the norm, hiring Indonesian...

Learn More

financial-resilience-service-indonesia-cekindo

Financial and Operational Resilience Services in Indonesia

To ensure sustainable growth, every business needs to mitigate risk an...

Learn More

Payroll Outsourcing Services in Indonesia

As your business grows, administrative tasks such as accounting and pa...

Learn More

Recruitment Agency in Indonesia

Recruitment Agency in Indonesia

Using a recruitment agent in Indonesia will help you hire the best can...

Learn More

Tax Consulting in Indonesia

No matter where you are doing business, it is important to stay 100% c...

Learn More

Tax Holiday Indonesia

Applying for The Tax Holiday in Indonesia

The Indonesian government promotes tax holidays as one of the fiscal i...

Learn More

Tax Litigation Indonesia

Tax Litigation Services in Indonesia

Operating businesses in Indonesia, entrepreneurs must comply with the ...

Learn More

Get Your Indonesian Visa, Hassle-Free

Immigration in Indonesia is one of the strictest and complex bureaucra...

Learn More

business visa indonesia

Get Your Indonesian Business Visa Securely

Whether obtaining a single-entry or multiple-entry business visa in In...

Learn More

dependent visa indonesia

Dependent Visa Indonesia: Grab It, Hassle-Free

Working in foreign countries and bringing your family with you require...

Learn More

Getting Investor KITAS Indonesia: The Ultimate Guide

Investor KITAS Indonesia is a stay permit that offers many benefits to...

Learn More

overseas visa for indonesian

Get The Overseas Visas for Indonesians Hassle-Free

Indonesian citizens needing a visa to travel abroad are often faced wi...

Learn More

KITAP indonesia

Obtaining a KITAP Indonesia: The Easiest Way

Getting a KITAP Indonesia might be the ultimate goal for every foreign...

Learn More

retirement visa indonesia

Retirement Visa Indonesia: How to Secure One

A blissful tropical climate and friendly people have attracted many fo...

Learn More

social visa indonesia

Social Visa Indonesia: How to Get One

Due to its simplicity, the Indonesian social visa has become popular a...

Learn More

spouse-visa-indonesia

Spouse Visa Indonesia: Obtain It With Ease

Foreigners who haven’t dealt with Indonesia’s immigration processe...

Learn More

indonesian tourist visa

Get Your Indonesian Tourist Visa

Blessed with stunning natural beauty and a highly diverse cultural her...

Learn More

visa on arrival indonesia

A Guide to Obtain an Indonesian Visa On Arrival

Foreigners from certain countries can minimize hassles when traveling ...

Learn More

KITAS Indonesia

A Seamless Way to Obtain A Work Permit in Indonesia

Expedite your Indonesian work permit application process by engaging w...

Learn More

Product Registration & Import Services

Product Registration Services Medical Devices Registration Food and Be...

Learn More

cosmetic product registration indonesia

Cosmetic Product Registration Services in Indonesia

With favorable trends and a promising outlook, companies entering Indo...

Learn More

export-from-indonesia

Start Exporting From Indonesia Today

Exports from Indonesia have seen a major contribution to the nation’...

Learn More

food and beverage product registration in indonesia

Product Registration in Indonesia: Food and Beverage

The Indonesian food and beverage industry presents lucrative investmen...

Learn More

halal certification indonesia

Halal Certification Indonesia: The Easiest Way

As the world’s most populous Muslim-majority country, Indonesian hal...

Learn More

health supplement product registration

Health Supplement Registration Services in Indonesia

With the increasing health awareness among its citizens, Indonesia’s...

Learn More

household product registration indonesia

Household Product Registration Services Indonesia

The rise of the middle-class in Indonesia has increased household spen...

Learn More

import license indonesia

Obtaining an Indonesian Import License

Indonesia’s growing middle class makes the country a perfect place t...

Learn More

Export-Indonesia4

Importer of Record Service: Importing Through A Partner

An Importer of Record in Indonesia is a legal service that enables com...

Learn More

medical device registration indonesia

Medical Device Registration Services in Indonesia

Given Indonesia’s reliance on imported medical devices, this sector ...

Learn More

Legal and Secretarial Services in Indonesia

Key Services Legal Consultation Legal Agreement Background Check and D...

Learn More

business document revision service in indonesia

Business Document Revision Services in Indonesia

Updating business documents to align with your company’s growth can ...

Learn More

due diligence and background check indonesia

Background Check and Due Diligence Services in Indonesia

Knowing with whom you are partnering and evaluating the risks before i...

Learn More

Understanding Indonesia’s Manpower Law

Understanding Indonesia’s manpower law might be difficult and time-c...

Learn More

legal agreement services in indonesia

Legal Agreement Services in Indonesia

To maximize return on investment, it is important to protect your own ...

Learn More

legal consultation services in indonesia

Legal Consultation Services in Indonesia

No matter where you are doing business, you must ensure your operation...

Learn More

Expanding into Indonesia in the most seamless way

...

Learn More

transfer pricing advisory indonesia

Transfer Pricing Advisory in Indonesia

Transfer pricing advisory is required to resolve complex transfer pric...

Learn More

Transfer Pricing Services in Indonesia

Transfer Pricing in Indonesia occurs when a company performs an intern...

Learn More

Expanding into Indonesia in the most seamless way

...

Learn More

how to open a bank acccount in indonesia

How to Open a Bank Account in Indonesia

Both natural and legal persons are entitled to open a bank account in ...

Learn More

buying agent

Buying Agent in Indonesia

InCorp Indonesia can help you find a trusted Buying Agent Indonesia fo...

Learn More

driving-license-indonesia

How to Get a Driving License in Indonesia

InCorp can help foreigners to get a driving license (SIM) in Indonesia...

Learn More

ESG advisory Indonesia

ESG Advisory Services in Indonesia

Adopting Environmental, Social, and Corporate Governance (ESG) practic...

Learn More

IMEI Registration Indonesia

IMEI Registration in Indonesia

IMEI Registration in Indonesia is necessary to ensure telecommunicatio...

Learn More

distributor in Indonesia

Find Local Partner and Distributor in Indonesia

With offices in Jakarta, Bali, Semarang, Surabaya, and Batam, InCorp I...

Learn More

Local Partner Selection in Indonesia

How to Find a Trusted Partner in Indonesia

Local Partner Selection in Indonesia - InCorp Indonesia can help you t...

Learn More

market research analysis

Market Research and Analysis Service in Indonesia

Improve your business by knowing the market conditions in Indonesia th...

Learn More

Mystery Shopping in Indonesia

InCorp Indonesia helps you to understand all information about your co...

Learn More

Personal Income Tax Calculator

Corporate Income Tax Calculator

Our Achievements

Medical Device Registration Services in Indonesia

Given Indonesia’s reliance on imported medical devices, this sector presents a treasured opportunity for foreign investors. Avoid any obstacles that may hurdle your business expansion objectives with medical device registration services in Indonesia..

Home
/
Product Registration & Import
/
Medical Device

Medical Device License: how to obtain one

The Indonesian government requires every medical device to be registered before entering the local market. The main government body that ensures the safety and compliance of these products is the Ministry of Health of the Republic of Indonesia (MOH).

Before issuing a medical device license, the MOH will evaluate and classify every product based on risk level by referring to Indonesian Ministry of Health regulations and guidances, ranging from class A (the lowest) to class D (the highest). In general, the higher the risk, the more complicated the document registration process. In this case, seeking assistance from experts will save time.

Requirements for medical device registration in Indonesia

The registration of medical devices in Indonesia starts with the eligible party applying through the MOH’s online system. The applicant must also submit several documents such as administration and technical quality documents, an executive summary of the product, a device description, risk analysis, and manufacturer information.

Providing these documents and aligning with the regulation and MOH requests can be challenging for foreign investors as they require an in-depth knowledge of processes. Even registered products are not entitled to enter the Indonesian market unless they are granted the Distribution License for Medical Devices.

Medical Device Registration Services in Indonesia with InCorp

STARTING A COMPANY
According to domestic law, only a legal company in Indonesia can register and distribute medical devices across the country. This could pose a great challenge for foreign investors to enter the market. As a notable market-entry consulting firm in Indonesia, InCorp, with its comprehensive business solutions, helps you with the registration of your company and assists you in obtaining a medical device import license with fewer hurdles.
PRODUCT LICENSE HOLDER
As a registered company with a Medical Device Distributor License (IDAK), InCorp is eligible to register medical devices in Indonesia.
EXTENSION OF DISTRIBUTION LICENSE
A medical device distribution license is valid for five years, and distributors need to extend the license at least nine months before it expires. Contact InCorp Indonesia to extend your license before it expires and avoid re-registration of your medical equipment.

According to domestic law, only a legal company in Indonesia can register and distribute medical devices across the country. This could pose a great challenge for foreign investors to enter the market. As a notable market-entry consulting firm in Indonesia, InCorp, with its comprehensive business solutions, helps you with the registration of your company and assists you in obtaining a medical device import license with fewer hurdles.

As a registered company with a Medical Device Distributor License (IDAK), InCorp is eligible to register medical devices in Indonesia.

A medical device distribution license is valid for five years, and distributors need to extend the license at least nine months before it expires. Contact InCorp Indonesia to extend your license before it expires and avoid re-registration of your medical equipment.

Medical Device Registration Services in Indonesia: The Workflow

Why Choose InCorp Indonesia for Medical Device Registration?

1

SEAMLESS PRODUCT REGISTRATION

With our expertise in Indonesia’s regulations, we handle the registration of your medical device with minimum obstacles.

2

WE ALWAYS HAVE SOLUTIONS

With or without establishing a company, we can get your medical devices registered securely and seamlessly.

3

ONE-STOP SERVICES

In addition to medical device registration, our consultants can get your medical products Halal certified in a seamless way.

4

TIME AND COST-SAVING

InCorp Indonesia handles your hefty paperwork requirements for product registration and rules out delays.

What Our Clients Say

After comparing several consultants, I found InCorp Indonesia is a international and professional organization with good understanding of local market. InCorp Indonesia helped our company to set up our first Indonesian entity, and also helps with day-to-day operation. InCorp Indonesia showed high level of professionalism. Jump start the business in Indonesia, take care of routine process, therefore we can focus more on our core business.

Cekindo provided outstanding services in registering our representative office in Indonesia in a timely manner. Their financial services have been helping us a lot — our local employees feel secure working for our company. Cekindo became our reliable partner with quick response on our needs. Their flexibility and full support of our business in Indonesia are the main reasons to continue in our cooperation.

We chose Cekindo because we considered Cekindo as a professional company with a good attitude and a streamlined business model. Cekindo met all our expectations as it created the atmosphere of accountability and transparency. The most significant added values that we received from cooperation with Cekindo are the time we saved and mistakes we avoided.

We were searching for suitable partner for the begining of our operation on Indonesian market. After short exploration and recommendation from our business partners we decided for Cekindo. Local knowledge, orientation at our business problematics, contacts and language. In a friendly approach combined with professional service. Consultation before the project – avoids so much unnecessary act of “foreigners” worse overview of the Indonesian legislative.

Herewith we want to express our appreciation to PT. Cekindo Business International and their team for all the support on medical devices services so far. We would like to take this opportunity to thank Cekindo for taking the time to listen to our needs. Whenever a need has arisen, we have always received their consistent, timely and quality support. We would not hesitate to recommend Cekindo team for any related activity or services.

Our Clients Find This Helpful. Please Review.

No votes yet.

Please wait...

© 2023 In.Corp Indonesia (formerly Cekindo). All Right Reserved. Privacy Policy. Terms & Conditions.

This site is registered on wpml.org as a development site.